Cicatrix, HypertrophicNCT03469830
The Development and Application of "Scar-care" Padding on Management of Hypertrophic Scar
A study testing SSCP and SPMS in people with Cicatrix, Hypertrophic and Rehabilitation, run by The Hong Kong Polytechnic University.
Trial summary
This study explores the smart scar care pad's potential therapeutic effect in treatment hypertrophic scar while elucidating the adverse effects if there is any. Half of the participant receives traditional treatment of pressure garment and the other half receives the smart scar care pad together with pressure garment. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Cicatrix, Hypertrophic, Rehabilitation
- What is being tested?
- SSCP and SPMS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2015to 1 Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with Hypertrophic Scar(HS);
- the HS had a total Vancouver Scar Scale (VSS) score of 4 or higher and the score of each item equal to or greater than 1;
- subjects age between 20 and 70 years, cooperative, and good compliance with treatment.
Who cannot join
- the HS area had an open wound or infection;
- the HS had been treated with steroid injections or other intervention (such as traditional Chinese medicine or laser therapy) before the study; or
- the patient had a medical condition that might affect wound healing (e.g., diabetes mellitus or another serious medical problem).
About this study
Official title: The Effectiveness of a Smart Scar Care Pad and Pressure Therapy Versus Pressure Therapy in Hypertrophic Scar Management: a Pilot Study
This study explores the smart scar care pad's potential therapeutic effect in treatment hypertrophic scar while elucidating the adverse effects if there is any. Half of the participant receives traditional treatment of pressure garment and the other half receives the smart scar care pad together with pressure garment.
- Conditions
- Cicatrix, Hypertrophic, Rehabilitation
- Being tested
- SSCP, SPMS
- Keywords
- insert, pressure therapy, silicone gel
- Medical subject headings
- Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSCPOther
Also called The Smart Scar Care PAd
Insert
SPMSOther
Also called The Smart Pressure Monitored Suit
Pressure therapy
| Study group | Role | What they receive |
|---|---|---|
| SSCP & SPMS | Experimental | The smart scar care pad (SCCP):
The SCCP is a newly invented insert material that can maximise treatment outcomes via enhanced compression and occlusion. The wearing regime for SCCP is 4 hours a day for the first day, with 2-hour increments added every other day until the total wearing time reached 23 hours. SSCP was cleaned twice a day for hygienic reasons.
The smart pressure monitored suit(SPMS):
The SPMS is a type of custom-made pressure garment. SPMS was used 23 hours a day and only removed when showering. Receives: Other: SSCP; Other: SPMS |
| SPMS | Active comparator | The smart pressure monitored suit(SPMS):
The SPMS is a type of custom-made pressure garment. SPMS was used 23 hours a day and only removed when showering. Receives: Other: SPMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Scar Pliability measured by the DermaLab Combo
Scar pliability is represented by the Young's modulus measured by the elasticity measurement of the DermaLab Combo
Measured: baseline and 6 weeks
Secondary outcomes (6)
Change of Scar Thickness measured by the diagnostic ultrasound system
Scar thickness is measured by the diagnostic ultrasound system
Measured: baseline and 6 weeks
Change of Scar Pigmentation measured by the DermaLab Combo
Scar pigmentation is represented by the melanin score generated by the color probe of the DermaLab Combo. The range of the score is 0-100, where a higher score indicates a higher melanin content.
Measured: baseline and 6 weeks
Change of Scar Vascularity measured by the DermaLab Combo
Scar vascularity is represented by the erythema score measured by the color probe of the DermaLab Combo. The range of the score is 0-100, where a higher score indicates a more erythematic situation.
Measured: baseline and 6 weeks
Occurrence of blistering
Occurence of blistering is observed and reported by research staff
Measured: up to 6 weeks
Occurrence of skin breakdown
Occurence of skin breakdown is observed and reported by research staff
Measured: up to 6 weeks
Occurrence of rash
Occurence of rash is observed and reported by research staff
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start1 Nov 2015
- Primary completion1 Nov 2016
- Study completion1 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cicatrix, HypertrophicStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469830
- Sponsor's protocol ID
- HSEARS20140618002-01
- Status last verified
- Mar 2018
- First submitted
- 13 Mar 2018
- Last updated
- 29 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Smart Scar Care Pad and Pressure Therapy Versus Pressure Therapy in Hypertrophic Scar Management: a Pilot Study
- ClinicalTrials.gov ID
- NCT03469830
- Acronym / sponsor ID
- HSEARS20140618002-01
- Conditions
- Cicatrix, Hypertrophic, Rehabilitation
- Keywords
- insert, pressure therapy, silicone gel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 1 Nov 2016 (actual)
- Study completion
- 1 Nov 2016 (actual)
- First posted
- 19 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study explores the smart scar care pad's potential therapeutic effect in treatment hypertrophic scar while elucidating the adverse effects if there is any. Half of the participant receives traditional treatment of pressure garment and the other half receives the smart scar care pad together with pressure garment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SSCP & SPMS | Experimental | Other: SSCP, Other: SPMSThe smart scar care pad (SCCP): The SCCP is a newly invented insert material that can maximise treatment outcomes via enhanced compression and occlusion. The wearing regime for SCCP is 4 hours a day for the first day, with 2-hour increments added every other day until the total wearing time reached 23 hours. SSCP was cleaned twice a day for hygienic reasons. The smart pressure monitored suit(SPMS): The SPMS is a type of custom-made pressure garment. SPMS was used 23 hours a day and only removed when showering. |
| SPMS | Active comparator | Other: SPMSThe smart pressure monitored suit(SPMS): The SPMS is a type of custom-made pressure garment. SPMS was used 23 hours a day and only removed when showering. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects with Hypertrophic Scar(HS);
- the HS had a total Vancouver Scar Scale (VSS) score of 4 or higher and the score of each item equal to or greater than 1;
- subjects age between 20 and 70 years, cooperative, and good compliance with treatment.
Key exclusion criteria (3 listed)
- the HS area had an open wound or infection;
- the HS had been treated with steroid injections or other intervention (such as traditional Chinese medicine or laser therapy) before the study; or
- the patient had a medical condition that might affect wound healing (e.g., diabetes mellitus or another serious medical problem).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SSCPAlso: The Smart Scar Care PAdInsert | Other | SSCP & SPMS |
| SPMSAlso: The Smart Pressure Monitored SuitPressure therapy | Other | SPMS, SSCP & SPMS |
Primary outcome
Change of Scar Pliability measured by the DermaLab Combo
Time frame: baseline and 6 weeks
Scar pliability is represented by the Young's modulus measured by the elasticity measurement of the DermaLab Combo
6 secondary outcomes
Change of Scar Thickness measured by the diagnostic ultrasound system
Time frame: baseline and 6 weeks
Change of Scar Pigmentation measured by the DermaLab Combo
Time frame: baseline and 6 weeks
Change of Scar Vascularity measured by the DermaLab Combo
Time frame: baseline and 6 weeks
Occurrence of blistering
Time frame: up to 6 weeks
Occurrence of skin breakdown
Time frame: up to 6 weeks
Occurrence of rash
Time frame: up to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing SSCP and SPMS in people with Cicatrix, Hypertrophic and Rehabilitation, run by The Hong Kong Polytechnic University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Scar Pliability measured by the DermaLab Combo (time frame: baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.